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Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity (SALIF)

Primary Purpose

Spinal Deformity

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Tantalum cage from Zimmer

About this trial

This is an interventional prevention trial for Spinal Deformity focused on measuring spine, deformity, instrumentation, ALIF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years or more of age
planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium

Exclusion Criteria:

malignancy
infection

Sites / Locations

Spine Unit, Rigshospitalet, 9 Blegdamsvej

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Anterior lumbar interbody fusion

Posterior instrumentation alone

Arm Description

Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach.

Posterior pedicle screw instrumentation

Outcomes

Primary Outcome Measures

Revision

Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure

Secondary Outcome Measures

Full Information

NCT ID

NCT01601054

First Posted

May 14, 2012

Last Updated

April 17, 2016

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT01601054

Brief Title

Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

Acronym

SALIF

Official Title

Supplemental Anterior Lumbar Interbody Fusion in Posterior Instrumented Fusion in Surgical Treatment of Spinal Deformities. A Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Within the last decade there has been an increase in the number of surgical procedures for deformities of the spine. This is caused by the increase in the elderly population, improved surgical techniques and an increased number of patients who have undergone previous surgical treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities bears a revision rate between 15 and 30% depending on definition, and one of the primary reasons for revision surgery is implant loosening in the lumbosacral region. The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar spine in addition to the usual posterior instrumentation can reduce the revision rate with 50%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Deformity

Keywords

spine, deformity, instrumentation, ALIF

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anterior lumbar interbody fusion

Arm Type

Active Comparator

Arm Description

Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach.

Arm Title

Posterior instrumentation alone

Arm Type

Active Comparator

Arm Description

Posterior pedicle screw instrumentation

Intervention Type

Device

Intervention Name(s)

Tantalum cage from Zimmer

Other Intervention Name(s)

Tantalum

Intervention Description

A tantalum cage will be inserted through a left sided retroperitoneal approach

Primary Outcome Measure Information:

Title

Revision

Description

Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years or more of age planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium Exclusion Criteria: malignancy infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benny Dahl, MD

Organizational Affiliation

University of Copenhagen, Rigshospitalet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Spine Unit, Rigshospitalet, 9 Blegdamsvej

City

Copenhagen

State/Province

Osterbro

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

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Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

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